Sunitinib G.L. Pharma 50 mg, harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

SUNITINIB 50 mg/stuk

Beschikbaar vanaf:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

INN (Algemene Internationale Benaming):

SUNITINIB 50 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; WITTE INKT, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; WITTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-11-26

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sunitinib G.L. Pharma 12,5 mg, harde capsules
Sunitinib G.L. Pharma 25 mg, harde capsules
Sunitinib G.L. Pharma 37,5 mg, harde capsules
Sunitinib G.L. Pharma 50 mg, harde capsules
sunitinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sunitinib G.L. Pharma is and what it is used for
2.
What you need to know before you take Sunitinib G.L. Pharma
3.
How to take Sunitinib G.L. Pharma
4.
Possible side effects
5.
How to store Sunitinib G.L. Pharma
6.
Contents of the pack and other information
1.
WHAT SUNITINIB G.L. PHARMA IS AND WHAT IT IS USED FOR
Sunitinib G.L. Pharma contains the active substance sunitinib, which
is a protein kinase inhibitor. It is
used to treat cancer by preventing the activity of a special group of
proteins which are known to be
involved in the growth and spread of cancer cells.
Sunitinib G.L. Pharma is used to treat adults with the following types
of cancer:
-
Gastrointestinal stromal tumour (GIST), a type of cancer of the
stomach and bowel, where
imatinib (another anticancer medicine) no longer works or you cannot
take imatinib.
-
Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that
has spread to other parts
of the body.
-
Pancreatic neuroendocrine tumours (pNET) (tumours of the
hormone-producing cells in the
pancreas) that have progressed or cannot be removed with surgery.
If you have any questions about how Sunitinib G.L. Pharma works or why
this medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib G.L. Pharma 12.5 mg, harde capsules
Sunitinib G.L. Pharma 25 mg, harde capsules
Sunitinib G.L. Pharma 37.5 mg, harde capsules
Sunitinib G.L. Pharma 50 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sunitinib G.L. Pharma 12.5 mg, harde capsules
Each capsule contains 12.5 mg of sunitinib.
Sunitinib G.L. Pharma 25 mg, harde capsules
Each capsule contains 25 mg of sunitinib.
Sunitinib G.L. Pharma 37.5 mg, harde capsules
Each capsule contains 37.5 mg of sunitinib.
Sunitinib G.L. Pharma 50 mg, harde capsules
Each capsule contains 50 mg of sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Sunitinib G.L. Pharma 12.5 mg, harde capsules
Gelatin capsules of size 4 (approximate length 14.3 mm) with orange
cap and orange body, printed
with white ink “12.5 mg” on the body and containing yellow to
orange granules.
Sunitinib G.L. Pharma 25 mg, harde capsules
Gelatin capsules of size 3 (approximate length 15.9 mm) with caramel
cap and orange body, printed
with white ink “25 mg” on the body and containing yellow to orange
granules.
Sunitinib G.L. Pharma 37.5 mg, harde capsules
Gelatin capsules of size 2 (approximate length 18.0 mm) with yellow
cap and yellow body, printed
with black ink “37.5 mg” on the body and containing yellow to
orange granules.
Sunitinib G.L. Pharma 50 mg, harde capsules
Gelatin capsules of size 1 (approximate length 19.4 mm) with caramel
cap and caramel body, printed
with white ink “50 mg” on the body and containing yellow to orange
granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
2
Sunitinib G.L. Pharma is indicated for the treatment of unresectable
and/or metastatic malignant
gastrointestinal stromal tumour (GIST) in adults after failure of
imatinib treatment due to resistance or
intolerance.
Metastatic renal cell carcinoma (MRCC)
Sunitinib G.L. Pharma is indicated for the treatment of
ad